PriMatrix for the Management of Diabetic Foot Ulcers

Not Applicable

Completed

Interventions: Device: PriMatrix Dermal Repair Scaffold
Device: Secondary Dressings
Device: Offloading device

Brief Summary: The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Detailed Description: A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely challenging as these ulcers may not respond to standard of care (SC) treatment and frequently become infected.

Advanced wound therapies like PriMatrix have become an important strategy in the treatment of hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
PriMatrix	PriMatrix Dermal Repair Scaffold	Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.
Standard of Care	Offloading device	Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.
Standard of Care	Secondary Dressings	Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.
PriMatrix	Offloading device	Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.
PriMatrix	Secondary Dressings	Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase	12-week Treatment Phase	Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.

Secondary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure, as Assessed by Computerized Planimetry.	12-week Treatment Phase
Rate of Wound Closure, as Assessed by Computerized Planimetry.	Weeks 1-12 during Treatment Phase	Rate of Wound closure was recorded as the percentage of the wound that was closed, per week. NOTE1: Rate (% closed/week) = 7 \* \[(Baseline wound size) - (Post-baseline wound size)\]/\[(Baseline wound size) \* (days in trial)\] NOTE2: Missing data is imputed using LOCF method for this analysis
Time to Complete Wound Closure, as Assessed by the Investigator	12-week Treatment Phase
Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase	12-week treatment phase

Locations (17): Wound Care of Tulsa
🇺🇸
Tulsa, Oklahoma, United States
LA Podiatry Group
🇺🇸
West Palm Beach, Florida, United States
JPS Health Network
🇺🇸
Fort Worth, Texas, United States
Martin Foot and Ankle
🇺🇸
York, Pennsylvania, United States
Georgetown University
🇺🇸
Washington, District of Columbia, United States
Futuro Clinical Trials
🇺🇸
McAllen, Texas, United States
Podiatry 1st
🇺🇸
Belleville, Illinois, United States
Foot and Ankle Institute
🇺🇸
Saint George, Utah, United States
The Mount Sinai Medical Center
🇺🇸
New York, New York, United States
LA Foot & Ankle Clinic
🇺🇸
Los Angeles, California, United States
Center for Clinical Research, Inc.
🇺🇸
San Francisco, California, United States
Podiatric Medical Partners of Texas, P.A.
🇺🇸
Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Element Research Group
🇺🇸
San Antonio, Texas, United States
ILD Research Center
🇺🇸
Carlsbad, California, United States
Central Valley Vein and Wound
🇺🇸
Selma, California, United States
Barry University Clinical Research
🇺🇸
North Miami, Florida, United States